MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXCELON; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	M00564101
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an excelon tbna needle was used in the bronchial during a bronchoscopy biopsy sample procedure performed on (b)(6) 2019.According to the complainant, while the doctor was preparing the needle outside of the patient to insert into the scope, a 2-3 cm piece of the sheath detached at the distal end of the device.The procedure was completed with a different needle.There were no patient complications reported as a result of this event.

• Brand Name: EXCELON
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8307558
• Report Number: 3005099803-2019-00390
• Device Sequence Number: 19241067
• Product Code: EOQ
• UDI-Device Identifier: 08714729456452
• UDI-Public: 08714729456452
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K040018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2020
• Device Model Number: M00564101
• Device Catalogue Number: 6410
• Device Lot Number: 0020791723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1